Final data on the eﬃcacy of the FORA study (FOrteca Real practice Assessment): a multicenter prospective observational study on the real-world eﬃcacy of prolgolimab in patients with metastatic melanoma in Russia

Kristina V. Orlova; Орлова Кристина Вячеславовна; Mikhail Iu. Fedyanin; Федянин Михаил Юрьевич; Konstantin E. Simanenkov; Симаненков Константин Эдуардович; Aleksandr S. Dergunov; Дергунов Александр Сергеевич; Petr R. Goldshmidt; Гольдшмидт Петр Рудольфович; Aleksandra F. Saydullaeva; Сайдуллаева Александра Федоровна; Darya V. Bogacheva; Богачева Дарья Вячеславовна; Marina A. Yavorskaya; Яворская Марина Алексеевна; Artur Z. Azanov; Азанов Артур Закирчанович; Alexander A. Fedenko; Феденко Александр Александрович; Larisa V. Bolotina; Болотина Лариса Владимировна; Tatyana I. Deshkina; Дешкина Татьяна Игоревна; Kseniya G. Babina; Бабина Ксения Геннадьевна; Ekaterina A. Kuzevanova; Кузеванова Екатерина Андреевна; Liudmila G. Zhukova; Жукова Людмила Григорьевна; Polina S. Feoktistova; Феоктистова Полина Сергеевна; Natalya I. Polshina; Польшина Наталья Ивановна; Ekaterina V. Peganova; Пеганова Екатерина Вячеславовна; Valentina E. Shikina; Шикина Валентина Евгеньевна; Maksim M. Sobolev; Соболев Максим Михайлович; Oleg V. Mironov; Миронов Олег Вячеславович; Vera A. Vaschenko; Ващенко Вера Александровна; Mariya M. Ershova; Ершова Мария Максимовна; Agniya O. Mezhueva; Межуева Агния Олеговна; Svetlana A. Orlova; Орлова Светлана Александровна; Denis A. Tantsyrev; Танцырев Денис Анатольевич; Darya K. Taskina; Таскина Дарья Константиновна; Antonina A. Teterich; Тетерич Антонина Анатольевна; Elena V. Karabina; Карабина Елена Владимировна; Yuliya V. Kostalanova; Косталанова Юлия Владимировна; Marina V. Bogacheva; Богачева Марина Владимировна; Natalia V. Zhukova; Жукова Наталья Владимировна; Rashida V. Orlova; Орлова Рашида Вахидовна; Maksim V. Zinkevich; Зинькевич Максим Вячеславович; Aleksandr I. Kazmin; Казьмин Александр Иванович; Mikhail V. Volkonskiy; Волконский Михаил Викторович; Liya M. Voronkova; Воронкова Лия Михайловна; Anastasiya S. Karpova; Карпова Анастасия Сергеевна; Mikhail L. Maleyko; Малейко Михаил Леонидович; Mariya N. Gorshenina; Горшенина Мария Николаевна; Elena I. Kryuchkova; Крючкова Елена Ивановна; Fedor V. Moiseenko; Моисеенко Федор Владимирович; Yuliya I. Murzina; Мурзина Юлия Ивановна; Shamil I. Musin; Мусин Шамиль Исмагилович; Andrey N. Ogloblin; Оглоблин Андрей Николаевич; Mariya S. Perminova; Перминова Мария Сергеевна; Regina A. Dumbrava; Думбрава Регина Анатольевна; Sergey A. Emelyanov; Емельянов Сергей Анатольевич; Svetlana A. Protsenko; Проценко Светлана Анатольевна; Alexander V. Sultanbaev; Султанбаев Александр Валерьевич; Anna V. Tarasova; Тарасова Анна Владимировна; Elena B. Shakhnovich; Шахнович Елена Борисовна; Marina V. Demchenkova; Демченкова Марина Викторовна; Yuliya A. Lozovskaya; Лозовская Юлия Александровна; Khedi S. Musaeva; Мусаева Хеди Салмановна; Elena M. Pavlova; Павлова Елена Михайловна; Roman A. Skotnikov; Скотников Роман Александрович; Vera V. Chernova; Чернова Вера Васильевна; Angelina S. Chichkanova; Чичканова Ангелина Семеновна; Adina M. Akhmatova; Ахматова Адина Муссаевна; Marina A. Zafirova; Зафирова Марина Ахилесовна; Andrey A. Mischenko; Мищенко Андрей Андреевич; Elena N. Ovsienko; Овсиенко Елена Николаевна; Viktoriya A. Petrukhnenko; Петрухненко Виктория Александровна; Oksana A. Syusyukaylova; Сюсюкайлова Оксана Анатольевна; Yana A. Tyugina; Тюгина Яна Александровна; Elena A. Shumilkina; Шумилкина Елена Александровна; Daniil L. Stroyakovskiy; Строяковский Даниил Львович; Aleksandr N. Yurchenkov; Юрченков Александр Николаевич; Pavel L. Baldin; Балдин Павел Леонидович; Anastasiya S. Belova; Белова Анастасия Сергеевна; Olga V. Diduk; Дидук Ольга Викторовна; Elena A. Konovalova; Коновалова Елена Александровна; Lyudmila N. Lebedeva; Лебедева Людмила Николаевна; Yaroslav A. Li; Ли Ярослав Андреевич; Viktoriya V. Mashtapa; Маштапа Виктория Валерьевна; Yana A. Mironenkova; Мироненкова Яна Александровна; Kristina V. Narovenkova; Наровенкова Кристина Васильевна; Olga A. Pavlikova; Павликова Ольга Аркадьевна; Elvira L. Parsadanova; Парсаданова Эльвира Левоновна; Irina S. Pimonova; Пимонова Ирина Сергеевна; Anna A. Ruzhnikova; Ружникова Анна Алексеевна; Irina D. Sivunova; Сивунова Ирина Догувна; Ekaterina P. Soloveva; Соловьева Екатерина Петровна; Maksim I. Sosnin; Соснин Максим Игоревич; Kh. Toita Temirsultanova; Темирсултанова Хасановна Тоита; Makhabbat Zh. Tyulegenova; Тюлегенова Махаббат Жикписбаевна; Aleksandra V. Khodkevich; Ходкевич Александра Васильевна; Nadezhda R. Shakurova; Шакурова Надежда Ревгатовна; Sureya N. Efendieva; Эфендиева Сурея Наджуллаховна; Karine L. Avagimyan; Авагимян Каринэ Левоновна; Ekaterina Р. Anokhina; Анохина Екатерина Павловна; Mariya I. Antoshkina; Антошкина Мария Ивановна; Stanislav M. Borzyanitsa; Борзяница Станислав Михайлович; Samir K. Dzhentemirov; Джентемиров Самир Кайтарбиевич; Marina V. Dmitrochenko; Дмитроченко Марина Владимировна; Alla V. Zheleznyak; Железняк Алла Викторовна; Yuliya V. Komoza; Комоза Юлия Валерьевна; Aleksandr S. Kopanev; Копанев Александр Сергеевич; Tatyana I. Kornienko; Корниенко Татьяна Ивановна; Margarita A. Krasilnikova; Красильникова Маргарита Андреевна; Darya A. Lukhmanova; Лухманова Дарья Александровна; Natalya S. Mazur; Мазур Наталья Сергеевна; Polina M. Markina; Маркина Полина Михайловна; Zhargal S. Mitapov; Митапов Жаргал Сергеевич; Svetlana N. Osodoeva; Осодоева Светлана Николаевна; Irina A. Prokopenko; Прокопенко Ирина Александровна; Irina M. Radyukova; Радюкова Ирина Михайловна; Madina S. Ramazanova; Рамазанова Мадина Султановна; Alfiya R. Safarova; Сафарова Альфия Риядовна; Mariya A. Safronova; Сафронова Мария Александровна; Khalimat M. Khabrieva; Хабриева Халимат Мухарбековна; Natalya S. Tsygankova; Цыганкова Наталья Сергеевна; Kseniya V. Chermakova; Чермакова Ксения Вадимовна; Tatyana A. Chirkova; Чиркова Татьяна Александровна; Igor V. Samoylenko; Самойленко Игорь Вячеславович; Valeria V. Nazarova; Назарова Валерия Витальевна; Angelina E. Akhmetyanova; Ахметьянова Ангелина Евгеньевна; Lev V. Demidov; Демидов Лев Вадимович

doi:10.26442/18151434.2024.1.202617

Final data on the eﬃcacy of the FORA study (FOrteca Real practice Assessment): a multicenter prospective observational study on the real-world eﬃcacy of prolgolimab in patients with metastatic melanoma in Russia

作者: Orlova K.¹, Fedyanin M.¹^,2^,3, Simanenkov K.⁴, Dergunov A.⁵, Goldshmidt P.⁴, Saydullaeva A.⁵, Bogacheva D.⁶, Yavorskaya M.⁷, Azanov A.⁸, Fedenko A.⁹, Bolotina L.⁹, Deshkina T.⁹, Babina K.¹⁰, Kuzevanova E.¹¹, Zhukova L.¹², Feoktistova P.¹², Polshina N.¹², Peganova E.¹³, Shikina V.¹⁴, Sobolev M.¹⁵, Mironov O.¹⁶, Vaschenko V.¹⁷, Ershova M.¹⁸, Mezhueva A.², Orlova S.¹⁹, Tantsyrev D.²⁰, Taskina D.²¹, Teterich A.²², Karabina E.²³, Kostalanova Y.²⁴, Bogacheva M.²⁵, Zhukova N.²⁶^,27, Orlova R.²⁷, Zinkevich M.²⁸, Kazmin A.⁶, Volkonskiy M.²⁹, Voronkova L.³⁰, Karpova A.³¹, Maleyko M.³², Gorshenina M.³³, Kryuchkova E.³⁴, Moiseenko F.³⁵, Murzina Y.³⁶, Musin S.³⁷, Ogloblin A.³⁸, Perminova M.⁸, Dumbrava R.³⁹, Emelyanov S.⁴⁰, Protsenko S.⁴¹, Sultanbaev A.³⁷, Tarasova A.²⁴, Shakhnovich E.⁴², Demchenkova M.⁴³, Lozovskaya Y.⁴⁴, Musaeva K.⁴⁵, Pavlova E.⁴⁶, Skotnikov R.²³, Chernova V.⁴⁷, Chichkanova A.⁴⁸, Akhmatova A.⁴⁹, Zafirova M.¹⁸, Mischenko A.³⁹, Ovsienko E.⁴⁰, Petrukhnenko V.⁵⁰, Syusyukaylova O.⁵¹, Tyugina Y.⁵², Shumilkina E.¹⁹, Stroyakovskiy D.²⁹, Yurchenkov A.²⁹, Baldin P.⁵³, Belova A.⁵⁴, Diduk O.⁵⁵, Konovalova E.⁵⁶, Lebedeva L.⁵⁷, Li Y.⁵⁸, Mashtapa V.⁴⁴, Mironenkova Y.⁴⁶, Narovenkova K.⁵⁹, Pavlikova O.³³, Parsadanova E.⁶⁰, Pimonova I.⁶¹, Ruzhnikova A.⁵⁷, Sivunova I.⁶², Soloveva E.⁵⁷, Sosnin M.⁶³, Temirsultanova K.⁴⁵, Tyulegenova M.⁶⁴, Khodkevich A.⁵⁹, Shakurova N.⁶⁵, Efendieva S.⁶⁶, Avagimyan K.⁴⁴, Anokhina E.⁶⁷, Antoshkina M.³³, Borzyanitsa S.⁸, Dzhentemirov S.⁶⁸, Dmitrochenko M.³⁴, Zheleznyak A.⁴⁸, Komoza Y.⁵⁹, Kopanev A.⁶⁹, Kornienko T.¹⁶, Krasilnikova M.⁸, Lukhmanova D.⁶⁷, Mazur N.¹⁸, Markina P.⁴⁸, Mitapov Z.⁷⁰, Osodoeva S.⁷⁰, Prokopenko I.⁴⁴, Radyukova I.⁷¹, Ramazanova M.⁶⁹, Safarova A.⁷², Safronova M.³⁴, Khabrieva K.⁷³, Tsygankova N.³⁴, Chermakova K.⁴⁴, Chirkova T.⁷⁴, Samoylenko I.¹, Nazarova V.¹, Akhmetyanova A.¹, Demidov L.¹
隶属关系:
1. Blokhin National Medical Research Center of Oncology
2. Moscow Multidisciplinary Clinical Center “Kommunarka”
3. Pirogov National Medical and Surgical Center
4. Lipetsk Regional Oncological Dispensary
5. Tver Regional Clinical Oncological Dispensary
6. Voronezh Regional Clinical Oncology Dispensary
7. Oncological Dispensary No. 2
8. Rappoport Kuzbass Clinical Oncological Dispensary
9. Hertsen Moscow Oncology Research Institute - branch of the National Medical Research Radiological Centre
10. Volgograd Regional Clinical Oncological Dispensary
11. Regional Clinical Oncological Dispensary, Saratov
12. Loginov Moscow Clinical Scientific Center
13. Clinical Oncology Hospital
14. Vladimirsky Moscow Regional Research Clinical Institute
15. Moscow City Oncological Hospital No. 1 of the Moscow Department of Healthcare
16. Tambov Regional Oncological Clinical Dispensary
17. Kostroma Oncological Dispensary
18. Sverdlovsk Regional Oncological Dispensary
19. Republican Clinical Oncological Dispensary
20. Altai Regional Oncological Dispensary
21. Chelyabinsk Regional Clinical Center of Oncology and Nuclear Medicine
22. Belgorod Regional Oncological Dispensary
23. Tula Regional Clinical Oncological Dispensary
24. Samara Regional Clinical Oncology Dispensary
25. Vologda Regional Clinical Hospital No. 2
26. Saint Petersburg State University
27. City Clinical Oncology Dispensary
28. Leningrad Regional Clinical Oncology Dispensary
29. Moscow City Oncological Hospital No. 62
30. Republican Oncological Dispensary, Vladikavkaz
31. Trans-Baikal Regional Oncological Dispensary
32. Oncological Dispensary, Shakhty
33. Republican Oncological Dispensary
34. Smolensk Regional Oncological Clinical Dispensary
35. Saint Petersburg Clinical Scientific and Practical Center for Specialized Types of Medical Care (Oncology)
36. Oncological Dispensary, Birobidzhan
37. Republican Clinical Oncology Center
38. Oryol Oncological Dispensary
39. Primorsky Regional Oncological Dispensary
40. Primushko Republican Clinical Oncological Dispensary
41. Petrov National Medical Research Center of Oncology
42. Korolyov City Hospital
43. Irkutsk Regional Oncological Dispensary
44. Ostroverkhov Kursk Cancer Research and Clinical Center
45. Oncology Center “AiMed”
46. Vologda Regional Oncological Dispensary
47. 8Regional Clinical Oncological Dispensary, Ryazan
48. Nizhny Novgorod Regional Clinical Oncology Center
49. Oncological Dispensary, Nalchik
50. Oncological Dispensary, Komsomolsk-on-Amur
51. Ashkhamaf Adyghe Republican Clinical Oncology Center
52. Ivanovo Regional Oncological Dispensary
53. Naberezhnye Chelny Oncological Dispensary - branch of the Republican Clinical Oncological Dispensary
54. Novgorod Regional Clinical Oncological Dispensary
55. Kryzhanovsky Krasnoyarsk Regional Clinical Oncology Dispensary
56. Murmansk Regional Oncological Dispensary
57. Arkhangelsk Clinical Oncology Dispensary
58. Clinic Lyadov
59. Bryansk Regional Oncological Dispensary
60. Sakhalin Regional Oncological Dispensary
61. Tsyb Medical Radiological Research Center - branch of the National Medical Research Radiological Center
62. Kamchatka Regional Oncology Center
63. Krasnogorsk City Hospital No. 1
64. Orenburg Regional Clinical Oncology Dispensary
65. Tomsk Regional Oncological Dispensary
66. Republican Cancer Center
67. Regional Clinical Oncology Dispensary, Ulyanovsk
68. Stavropol Regional Clinical Oncology Center
69. Center of Oncology and Medical Radiology
70. Buryat Republican Clinical Oncological Dispensary
71. Clinical Oncological Dispensary
72. Almetyevsk branch of the Republican Clinical Oncological Dispensary
73. Republican Oncological Dispensary, Nazran
74. Rappoport Novokuznetsk branch of the Kuzbass Clinical Oncological Dispensary
期: 卷 26, 编号 1 (2024)
页面: 20-34
栏目: Articles
URL: https://journals.rcsi.science/1815-1434/article/view/258570
DOI: https://doi.org/10.26442/18151434.2024.1.202617
ID: 258570

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Background. Prior to the introduction of new agents — immune checkpoint inhibitors — for inoperable and/or metastatic melanoma (IMM), chemotherapy outcomes were generally poor. The median (Me) overall survival (OS) in IMM was no more than 6-9 months, and the Me of progression-free survival (PFS) was about 2 months. The introduction of immune checkpoint inhibitors and targeted therapy changed the prognosis for the life of IMM patients dramatically. The development, studies, and approval of a new original PD-1 inhibitor, prolgolimab, in Russia in 2020 prompted the professional community to conduct a prospective observational study in the Russian Federation to assess its real-world efficacy and safety.

Aim To evaluate the real-world efficacy and safety of prolgolimab in patients with IMM.

Materials and methods. From October 2020 to October 2022, 700 patients with IMM receiving prolgolimab in real clinical settings in oncological institutions of various levels in the Russian Federation were included in the study. The main inclusion criteria were: pathology-confirmed diagnosis of melanoma; metastatic and/or inoperable type; use of prolgolimab outside of clinical trials; and signed informed consent. Objective response rate in the general population and the Intention-to-treat and Per Protocol populations was considered the main criterion for evaluating the efficacy of therapy, and the safety criterion was the incidence of grade 3-4 adverse events (AEs). PFS and OS rates were also assessed. Statistical analysis was performed using the SPSS 25.0 software package.

Results. The objective response rate for the Per Protocol population (with radiographic assessment available) was 42% (n=235/559). Disease progression was reported in 26.7% (n=149) of patients, stabilization in 31.3% (n=175), and disease control in 73.3% of patients with IMM, regardless of the line of therapy. At the follow-up Me of 12 months (0-36), PFS for all patients regardless of the line of therapy was 8 months (95% confidence interval [Cl] 6.537-9.463), 6-month PFS was 55%, and 12-month PFS was 41%. OS Me for all included patients was 32 months, 6-month OS was 82%, and 12-month OS was 69%. Depending on the line of therapy, the OS Me was: line 1 - not reached, line 2-30 months (95% Cl 16.007-43.993), line 3 and subsequent- 22 months (95% Cl 14.264-29.736); p=0.736. According to the CTCAE 5.0 general terminology criteria for AEs, a total of 136/693 (19.6%) AEs of varying degrees were reported, in particular: grade 1-2 - 105/693 (15.2%), grade 3-4 - 25/693 (3.6%), unknown grade - 5/693 (0.7%), as well as one fatal case (0.1%) due to thromboembolism in the vascular center with an unclear (according to the investigator's assessment) relation with prolgolimab.

Conclusion The results obtained at 12 months of follow-up confirm the high efficacy and satisfactory tolerability of prolgolimab in patients with IMM in real-world practice, regardless of the line of therapy and other characteristics.

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metastatic melanoma, prolgolimab, anti-PD-1, prospective observational study, BRAF, FORA, skin melanoma

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Kristina Orlova

Blokhin National Medical Research Center of Oncology

Email: krisman03@gmail.com
ORCID iD: 0000-0002-0442-5917

Cand. Sci. (Med.)

俄罗斯联邦, Moscow

Mikhail Fedyanin

Blokhin National Medical Research Center of Oncology; Moscow Multidisciplinary Clinical Center “Kommunarka”; Pirogov National Medical and Surgical Center

Email: fedianinmu@mail.ru
ORCID iD: 0000-0001-5615-7806
SPIN 代码: 4381-5628

D. Sci. (Med.)

俄罗斯联邦, Moscow; Moscow; Moscow

Konstantin Simanenkov

Lipetsk Regional Oncological Dispensary

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Final data on the eﬃcacy of the FORA study (FOrteca Real practice Assessment): a multicenter prospective observational study on the real-world eﬃcacy of prolgolimab in patients with metastatic melanoma in Russia

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